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FDA 510(k)

React 68 Catheter

K-Number: K180715 · 2018-07-04

ApplicantMicro Therapeutics, Inc. d/b/a ev3 Neurovascular
Decision Date2018-07-04
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

React 68 Catheter is a medical device manufactured by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. It received FDA 510(k) clearance on 2018-07-04 under approval number K180715. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the React 68 Catheter?

React 68 Catheter is a medical device that received FDA 510(k) clearance on 2018-07-04. It is manufactured by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. The 510(k) number is K180715.

When was React 68 Catheter approved by the FDA?

React 68 Catheter received FDA 510(k) clearance on 2018-07-04, under approval number K180715.

What company makes React 68 Catheter?

React 68 Catheter is manufactured by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular.

What is the FDA product code for React 68 Catheter?

The FDA product code for React 68 Catheter is DQY.

Other Devices by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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